Surgical Knife
FDA 510(k) K861947 · Sharpoint, Inc.
510(k) numberK861947
Submission
- Device name
- Surgical Knife
- Applicant
- Sharpoint, Inc.
Reading, PA, US - Received
- May 20, 1986
- Decision date
- June 6, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EMF – Knife, Surgical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code EMF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K080133 | Mountable Endoscopic BladeEMF · Traditional | A.M. Surgical, Inc. | 03/13/2008SE |
| K982142 | Mountable Endoscopic KnifeEMF · Traditional | A.M. Surgical, Inc. | 12/30/1998SE |
| K890217 | Microsurgical KnivesEMF · Traditional | Kinetic Medical Products | 01/27/1989SE |
| K890215 | Microsurgical ScarifierEMF · Traditional | Kinetic Medical Products | 01/27/1989SE |
| K890214 | Microsurgery Razor Blade HolderEMF · Traditional | Kinetic Medical Products | 01/27/1989SE |
| K880094 | Van-Tec Endopyelotomy KnifeEMF · Traditional | Van-Tec, Inc. | 02/29/1988SE |
| K863752 | Valtrac (Bar) Remover DeviceEMF · Traditional | Davis & Geck, Inc. | 10/24/1986SE |
| K863549 | Reusable/Disposable Autopsy Knife SetEMF · Traditional | Surgipath Medical Industries, Inc. | 09/30/1986SE |
| K854891 | KnifeEMF · Traditional | Euro-Med Intl. | 05/02/1986SE |
| K851784 | 27-210 Plaster Knife (Reiner)EMF · Traditional | Artiberia | 06/20/1985SE |
More from Artiberia
| 510(k) | Device | Decision |
|---|---|---|
| K863595 | Coated Suture NeedleGAB · Traditional | 10/24/1986SE |
| K840764 | Ear KnivesJYO · Traditional | 05/21/1984SE |
| K840855 | Corneal Scleral LanceHNN · Traditional | 05/09/1984SE |
| K840660 | Posterior Capsulotomy CystitomeHNY · Traditional | 03/16/1984SE |
| K840659 | Anterior Capsulectomy CystitomeHNY · Traditional | 03/16/1984SE |
| K830522 | Stainless Steel Suture 316L · Traditional | 03/31/1983SE |
| K822112 | Ophthalmic KnifeHNN · Traditional | 08/10/1982SE |
| K821440 | V LanceHNN · Traditional | 06/14/1982SE |
Questions and answers
When was Surgical Knife cleared by the FDA?
Surgical Knife (K861947) received a 510(k) decision of Substantially Equivalent on June 6, 1986, 17 days after the submission was received.
What is the product code of K861947?
The FDA product code is EMF – Knife, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4800.